The Food and Drug Administration announced a completion of a comprehensive safety review that focused on the fatty acid amide hydrolase (FAAH) inhibitor drug used in the deadly clinical trial that occurred in France earlier this year.
Information obtained from the European Medicines Agency and the French National Medicines Agency helped the FDA decide that the candidate used in the trial hosted by French CRO Biotrial on behalf of Portuguese pharmaceutical firm Bial exhibited “a unique toxicity that does not extend to other drugs in the class,” according to the agency’s official statement.
Currently, there are no clinical trials related to FAAH inhibitors scheduled to occur in the U.S. this year. However, the FDA pledged to work with sponsors to lay the foundation for appropriate testing for FAAH inhibitors in the U.S. along with ensuring all parties linked to these clinical trials are well aware of the benefits and risks.
Previous test trials of FAAH inhibitors didn’t raise safety concerns in the past, but the trial in France raised concerns when it was reported six participants had taken a higher dose of the drug, reported FierceBiotech. All six volunteers were rushed to the hospital where one fell into a coma before passing away while the others remained hospitalized and later recovered.
Some reports of Biotrial and Bial had criticized the way the companies helped these patients after giving them a high dose of the drug and shared information with authorities in the aftermath of this event.
Filed Under: Drug Discovery
